The U.S. Food and Drug Administration (FDA) has given approval to a clinical trial on psilocybin, the psychedelic ingredient found in magic mushrooms.
COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received approval from the FDA for a clinical trial in psilocybin therapy for treatment-resistant depression. Regulatory approvals for the trial have already been given in the UK, the Netherlands and Canada.
The trial is a phase IIb dose-ranging study with 216 patients taking part in 12 to 15 research sites across Europe and North America. It will begin in the UK later this month and sites in other countries will join the trial as further regulatory approvals are received.
Psilocybin therapy combines a dose of psilocybin (a psychoactive medicine and the active ingredient in “magic mushrooms”) with psychological support, and has shown promising signals of efficacy and safety as treatment for depression in academic studies in the UK and US. If the trial is successful, it will be followed by phase III studies.
George Goldsmith, Chairman and Co-founder of COMPASS Pathways, said, “We are excited to be starting this landmark trial which has the potential to transform lives. Depression is the leading cause of ill-health and disability worldwide, and treatment-resistant depression affects more than 100 million people. It is a huge unmet need and the trial will teach us more about how this new approach might address it.”
Ekaterina Malievskaia, Chief Medical Officer and Co-founder of COMPASS, said: “The design of this study has been a truly collaborative effort, with scientists, clinicians, patient representatives and regulators from Europe and North Americaworking together with the goal of helping patients suffering with treatment-resistant depression.”